Cleared Traditional

PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F

K884394 · Ela Medical, Inc. · Cardiovascular
Dec 1988
Decision
55d
Days
Class 3
Risk

About This 510(k) Submission

K884394 is an FDA 510(k) clearance for the PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F, a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Ela Medical, Inc. (Minnetonka, US). The FDA issued a Cleared decision on December 8, 1988, 55 days after receiving the submission on October 14, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K884394 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1988
Decision Date December 08, 1988
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTB — Permanent Pacemaker Electrode
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3680

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